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Terminated

Atakr II RF Power Generator, Models 4802 and 4803

FDA Recall Z-0618-03 · Posted 2003-03-06

Recalling FirmMedtronic,Inc/Rice Creek Facil
Recall StatusTerminated
Product CodeDQY
Date Initiated2002-11-25
Date Terminated2003-11-04
Product Quantity775 units

Reason for Recall

An RF pulse occurs each time the temperature set point increase button is activated while ablating and this can result in heart rhythm disturbances.

Firm Action

An "Important Product Management Information" letter dated November 25, 2002 was sent to the affected consignees (hospitals) and it recommended certain actions to avoid the problem and stated that a software revision, (version 1.36) had been developed to eliminate the problem.

Root Cause

Other

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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